A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Gary Morrow
- 入组人数
- 745
- 试验地点
- 19
- 主要终点
- Change From Baseline of Peak Acute Nausea
研究概览
简要总结
RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs are more effective with or without ginger in treating nausea caused by chemotherapy.
PURPOSE: This randomized phase II/III trial is studying giving antiemetic drugs together with ginger to see how well they work compared to antiemetic drugs alone in treating nausea in patients who are receiving chemotherapy for cancer.
详细描述
OBJECTIVES:
- Compare the efficacy of 1 course of ginger vs placebo when administered in regimens containing a 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic and dexamethasone (or the equivalent dose of IV methylprednisolone) in controlling chemotherapy-related nausea at course 2 of chemotherapy in patients with cancer.
- Compare the efficacy of 3 different doses of ginger in controlling chemotherapy-related nausea in these patients.
- Determine the adverse effects of ginger when given 3 days before chemotherapy administration in these patients.
- Determine the adverse effects of these antiemetic regimens during the 4 days after chemotherapy.
- Compare the chemotherapy-related anticipatory nausea in patients treated with these antiemetic regimens.
- Compare the quality of life during the 4 days after chemotherapy in patients treated with these antiemetic regimens.
- Compare the chemotherapy-related nausea at course 3 of chemotherapy in these patients after 2 courses of ginger vs placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 4 treatment arms. Day 1 of each course is defined as the day of chemotherapy administration.
- Placebo: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
- 0.5g Ginger: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
- 1.0g Ginger: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
- 1.5g Ginger: Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
Patients in each arm also continue receiving their scheduled antiemetic regimen comprising a 5-hydroxytryptamine type-3 (5-HT3) receptor antagonist (ondansetron, granisetron, tropisetron, and dolasetron mesylate) and dexamethasone (DM) (or the equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of courses 2 and 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of cancer and be scheduled to receive at least 3 courses of chemotherapy
- •Scheduled to receive chemotherapy with no planned interruption by radiotherapy or surgery
- •Chemotherapy courses must be separated by at least 2 weeks from day 1 to day 1 of next course
- •Must have experienced nausea of any degree of severity after completion of the first study-related course of chemotherapy
- •Received a prior 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) with dexamethasone (DM) given at any dose and by any route (or equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of course 1 of chemotherapy
- •Scheduled to receive a 5-HT3 receptor antagonist antiemetic with DM (or equivalent dose of IV MePRDL) on day 1 of courses 2 and 3 of chemotherapy
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count greater than 100,000/mm^3 at second course of chemotherapy
- •No prior bleeding or blood coagulation disorder (e.g., thrombocytopenia or platelet dysfunction)
- •No prior coagulation factor deficiency
- •Not specified
- •Cardiovascular:
- •No prior vascular defect
- •Able to understand English
- •No concurrent or impending bowel obstruction
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent interferon therapy
- •Chemotherapy:
- •See Disease Characteristics
- •At least 6 months since other prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •No concurrent radiotherapy
- •See Disease Characteristics
- •No concurrent warfarin or heparin for therapeutic anticoagulation
- •Concurrent low-dose warfarin for maintenance of venous access allowed
- •Concurrent rescue medications for control of symptoms caused by the cancer or its treatment allowed as clinically indicated
排除标准
- 未提供
研究组 & 干预措施
Placebo
Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
干预措施: placebo (Other)
0.5g ginger
Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
干预措施: placebo (Other)
1.0g ginger
Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
干预措施: placebo (Other)
1.5g ginger
Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
干预措施: ginger (Dietary Supplement)
1.0g ginger
Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
干预措施: ginger (Dietary Supplement)
0.5g ginger
Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
干预措施: ginger (Dietary Supplement)
结局指标
主要结局
Change From Baseline of Peak Acute Nausea
时间窗: 3-4 days on study drug
Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings. Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure. Negative values for this outcome are favorable.
次要结局
- Average Nausea Severity(3-4 days on study drug)
研究者
Gary Morrow
Director, URCC CCOP Research Base
University of Rochester